Device recall

Z-2581-2024: Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with…

FDA device recall · Class II · Baxter Healthcare Corporation

Key facts

Recall number (Z-number) Z-2581-2024
Recall event 94988
Product Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spectrum V8 Infusion Pump
Product code FRN
Recalling firm Baxter Healthcare Corporation
Recall class Class II
Status Open, Classified
510(k) numbers K230022
FEI number 1417572

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)